Aesculap Absorbable Craniofix
FDA 510(k) K040080 · Aesculap, Inc.
510(k) numberK040080
Submission
- Device name
- Aesculap Absorbable Craniofix
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- January 15, 2004
- Decision date
- March 31, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional | Orthocon, Inc. | 03/16/2026SE |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special | Neos Surgery S.L | 02/16/2024SE |
| K221606 | Absorbable Cranial Flap Fixation SystemGXR · Traditional | Chendu Medart Medical Scientific Co., Ltd. | 11/21/2023SE |
| K192310 | Flap Fixator, Burr Hole CoverGXR · Traditional | Ossaware Biotech Co., Ltd. | 06/03/2020SE |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateGXR · Traditional | Neurovention, LLC | 03/13/2020SE |
| K181539 | OSSDSIGN CranioplugGXR · Traditional | Ossdsign AB | 10/12/2018SE |
| K181382 | GuardianTM Burr Hole Cover SystemGXR · Abbreviated | St Jude Medical | 07/20/2018SE |
| K160739 | Cranial COVERGXR · Traditional | Neos Surgery S.L | 06/12/2016SE |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional | St Jude Medical | 06/09/2016SE |
| K140309 | CranioplugGXR · Traditional | Ossdsign AB | 10/03/2014SE |
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| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
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Questions and answers
When was Aesculap Absorbable Craniofix cleared by the FDA?
Aesculap Absorbable Craniofix (K040080) received a 510(k) decision of Substantially Equivalent on March 31, 2004, 76 days after the submission was received.
What is the product code of K040080?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.